The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Carescape Respiratory Modules, E-sco, E-scov, E-scovx, E-scaio, E-scaiov, E-scaiovx.
| Device ID | K150245 |
| 510k Number | K150245 |
| Device Name: | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Contact | Mari Salmenkaita |
| Correspondent | Mari Salmenkaita GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Product Code | CCK |
| Subsequent Product Code | BZK |
| Subsequent Product Code | BZL |
| Subsequent Product Code | CAP |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCL |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104289 | K150245 | 000 |
| 00840682104067 | K150245 | 000 |
| 00840682104258 | K150245 | 000 |
| 00840682104180 | K150245 | 000 |
| 00840682104173 | K150245 | 000 |
| 00840682104142 | K150245 | 000 |
| 00840682102919 | K150245 | 000 |
| 20840682102883 | K150245 | 000 |